Prescription Drugs

A prescription drug is a licensed medicine that is regulated by legislation to require a prescription before it can be obtained. The term is used to distinguish it from over-the-counter drugs which can be obtained without a prescription. Different jurisdictions have different definitions of what constitutes a prescription drug.

Regulations in the United States:

In the United States, the Federal Food, Drug, and Cosmetic Act define what requires a prescription. Prescription drugs are generally authorized by veterinarians, dentists, optometrists, and medical practitioners. It is generally required that an MD, DO, PA, OD, DPM, DVM, DDS, or DMD write the prescription; basic-level registered nurses, medical assistants, clinical nurse specialists, nurse anesthetists, and nurse midwives, emergency medical technicians, psychologists, and social workers as examples, do not have the authority to prescribe drugs.

The package insert for a prescription drug contains information about the intended effect of the drug and how it works in the body. It also contains information about side effects, how a patient should take the drug, and cautions for its use, including warnings about allergies.

The safety and effectiveness of prescription drugs in the US is regulated by the federal Prescription Drug Marketing Act of 1987. The Food and Drug Administration is charged with implementing this law. As a general rule, over the counter (OTC) drugs are used to treat conditions not necessarily requiring care from a health care professional and have been proven to meet higher safety standards for self-medication by patients. Often a lower strength of a drug will be approved for OTC use, while higher strengths require a prescription to be obtained; a notable case is ibuprofen, which has been widely available as an OTC pain killer since the mid-1980s but is still available by prescription in doses up to four times the OTC dose for use in cases of severe pain not adequately controlled by the lower, OTC strength.

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